NCT00934414

Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes

A Parallel, Controlled, Multi-Center, Single-Dose, One-Period Euglycemic Clamp Study Comparing Prandial Inhalation of Technosphere Insulin in Smokers and Non-Smokers With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin in the body during a clamp procedure.

Detailed description

MKC-TI-016 is a parallel, prospective, controlled, open-label, 1-period, single-dose trial utilizing a hyperinsulinemic-euglycemic clamp procedure to evaluate the bioavailability and bioeffect of inhaled TI Inhalation Powder in type 2 diabetic subjects who smoke compared to nonsmoking type 2 diabetic subjects.

Conditions

• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Technosphere Insulin Inhalation Powder	30U

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-08-01
• Completion: 2006-09-01
• First posted: 2009-07-08
• Last updated: 2009-07-08

Locations

1 site across 1 country: United States